Determination of ethinyl estradiol in solid dosage forms by high-performance liquid chromatography

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Accurate quantification of ethinyl estradiol in solid dosage forms is crucial for pharmaceutical quality control.
• Existing analytical methods may lack the speed, reproducibility, or stability-indicating capabilities required for comprehensive drug analysis.

Purpose of the Study:

• To develop and validate a rapid, reproducible, and stability-indicating high-performance liquid chromatographic (HPLC) method for ethinyl estradiol determination.
• To assess the method's applicability to various solid dosage forms, including combination products.

Main Methods:

• Development of a reversed-phase HPLC system utilizing a specific mobile phase composition (0.05 M aqueous KH2PO4-methyl alcohol, 2:3).
• Implementation of fluorescence detection for enhanced sensitivity.
• Validation of the method for stability indicating capabilities, single tablet assays, stability samples, and dissolution studies.

Main Results:

• The developed HPLC method demonstrated high accuracy, with recovery rates ranging from 97.3% to 101.5% for stability and single-tablet assays.
• Dissolution assays showed excellent recovery (95.4% to 102.2%).
• High reproducibility was confirmed, with relative standard deviations between 0.4% and 2.2% across various applications.

Conclusions:

• A rapid, reproducible, and stability-indicating HPLC method with fluorescence detection has been successfully developed for ethinyl estradiol analysis.
• The method is suitable for quality control of ethinyl estradiol in solid dosage forms, including stability testing and dissolution profiling.
• This validated assay provides a reliable tool for ensuring the quality and efficacy of ethinyl estradiol-containing medications.